FDA 510(k)

橫越支撐導管

K 號：K183305 · 2019-08-05

決定日期2019-08-05

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Crossing Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Tractus Vascular, LLC. It received FDA 510(k) clearance on 2019-08-05 under 510(k) number K183305. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Crossing Support Catheter?

Crossing Support Catheter is a medical device that received FDA 510(k) clearance on 2019-08-05. The listed applicant is Tractus Vascular, LLC. The 510(k) number is K183305.

When did Crossing Support Catheter receive FDA 510(k) clearance?

Crossing Support Catheter received FDA 510(k) clearance on 2019-08-05, under 510(k) number K183305.

Who is the listed applicant for Crossing Support Catheter?

The FDA 510(k) record lists Tractus Vascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Crossing Support Catheter?

The FDA product code for Crossing Support Catheter is DQY.

其他以 Tractus Vascular, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K221163隧道穿越導管 K180889Tractus Crossing 支援導管

相關器械（代碼：DQY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262817CrossFAST整合式微导管先進輸送系統Vantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift 管針Alembic, LLC K262240SSPC NXT 輸送導管CenterPoint Systems, LLC K261766CPS 定位器 3D Plus 輸送导管CenterPoint Systems, LLC K261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

官方來源

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